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Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial.

Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial.
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Rockstroh JK, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J,


Rockstroh JK, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J, (click to view)

Rockstroh JK, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J,

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Antiviral therapy 2016 12 07() doi 10.3851/IMP3116

Abstract
BACKGROUND
In the primary 48-week analysis of a hepatic safety trial in patients with HIV-1 co-infected with hepatitis B virus (HBV) and/or hepatitis C virus (HCV), maraviroc-containing treatment regimens were not associated with increased hepatotoxicity.

METHODS
In this randomised, double-blind, placebo-controlled, multicentre study, patients received maraviroc twice daily (n=70) or placebo (n=67) with concomitant antiretroviral therapy for 144 weeks (clinicaltrials.gov identifier, NCT01327547). The primary endpoint was the proportion of patients with protocol-defined Grade 3/4 alanine aminotransferase (ALT) abnormalities through week 48. Key secondary endpoints included 144-week analysis of Grade 3/4 ALT abnormalities and liver fibrosis by enhanced liver fibrosis (ELF) testing, hepatic elastography, and an optional biopsy substudy.

RESULTS
Through 144 weeks of treatment, 2 (maraviroc) and 3 (placebo) patients met the protocol-defined Grade 3/4 ALT endpoint. Similar to the 48-week results, there were no statistically significant differences between groups in change from baseline in ELF or hepatic elastography. However, decreased elastography scores were noted in the maraviroc group. Blinded pathologist review suggested that 2 of 11 paired biopsies (both on MVC) showed signs of decreased fibrosis. One (maraviroc) and 2 (placebo) patients experienced treatment-related hepatobiliary adverse events (AEs). Five patients in the maraviroc group discontinued because of treatment-related AEs vs 3 in the placebo group. One death in the maraviroc group and 2 deaths in the placebo group were reported.

CONCLUSIONS
Use of maraviroc did not increase hepatotoxicity in this population through 144 weeks. Further investigation regarding possible beneficial effects of maraviroc on liver fibrosis may be warranted.

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